Celgene's Revlimid wins US lymphoma approval

FDA recommends extra indication for blockbuster cancer drug

Celgene's blockbuster drug Revlimid is on course for even bigger sales after winning US FDA approval for use in the treatment of the rare blood cancer mantle cell lymphoma.

Revlimid (lenalidomide) is already the company's biggest selling product, taking in $3.8bn during 2012 for its current multiple myeloma and anaemia indications, but Celgene will now have access to a new haematology market in the US for an indication with few treatment options.

Mantle cell lymphoma is an aggressive subtype of non-Hodgkin's lymphoma (NHL), occurring in less than 10 per cent of patients with NHL, for which there are about 65,000 new cases a year in the US.

It is so-called because it affects the 'mantle' zone, or outer edge, of lymph nodes, and disease progression is common after chemotherapy.

Revlimid's approval for the condition covers the drug's use in patients whose disease has relapsed or progressed after two prior therapies, one of which must include Velcade (bortezomib), marketed in the US by Takeda subsidiary Millennium Pharmaceuticals.

Administered as an injection, Velcade was approved in the US in 2007 to treat patients with mantle cell lymphoma who had received at least one type of therapy, and the drug has gone on to be a success for Takeda/ Millennium, achieving sales in 2012 of more than $700m.

The extra indication for Revlimid could help push the drug's annual revenues to almost $6bn by 2016, analysts Bloomberg.

“There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma,” said Dr Andre Goy, chairman and director, John Theurer Cancer Center at Hackensack UMC and chief science officer and director of research and innovation at Regional Cancer Care Associates, LLC.

“The approval of lenalidomide delivers a new option, and the first oral therapy in this area of lymphoma,” he added.

The news is especially welcome for Celgene, considering recent missteps for Revlimid. These have included the company's decision in 2011 to halt a phase III trial investigating the drug's use in prostate cancer after data demonstrated no overall survival benefit, and then in 2012 the company withdrew its EU application for earlier use of the drug in multiple myeloma.